Preventing Temperature Abuse - Pharmaceutical Technology

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Preventing Temperature Abuse
Innovations protect the quality of temperature-sensitive products.


Pharmaceutical Technology
Volume 35, Issue 2, pp. 34-37

Temperature monitoring

Data loggers provide a warning if the contents of an insulated package or container experienced heat or cold beyond acceptable parameters. The devices permit immediate decisions about product quality. The ability to upload temperature data from the monitor as soon as the shipment arrives eliminates delays and quarantine time associated with waiting for a monitor to be returned for analysis or a report to be faxed (Shipping Temperature Electronic Monitoring System, Almac Clinical Services).

A specialty courier service tracks the temperature and movement of sensitive shipments in real time through a customized global positioning system (GPS)-based device. It also can provide chain-of-custody data (GPS Tracking devices, GTX, for MNX).

Integrating a satellite network with tracking software achieves similar functionality. The two-way communication between shipping container and shipper or recipient enables real-time product tracking and management and provides an early warning if temperatures deviate beyond desired parameters (SmartLink Platform, Axeda, and satellite network, ORBCOMM).

Yet another way to track temperatures inside shipping containers relies on an active radio-frequency identification (RFID) tag equipped with a satellite modem and GPS receiver. If an RFID reader is within range, the tag communicates with it. If not, it uses the satellite modem to upload environmental data and location coordinates (GlobalTag ST-694 and SmartChain software, Savi Networks).

Another RFID-based data logger also relies on an RFID tag–temperature sensor combination. The semipassive tag is compatible with most Gen2 ultrahigh-frequency RFID readers and features a thin profile, easy-to-use manual interface, and 16 configurable temperature ranges between –20 and 70 C. As many as 4000 data points can be collected. Algorithms calculate the product's remaining shelf life to provide data to support a decision to deliver or return a product that has experienced temperature abuse. Deutsche Post DHL has adopted the technology for its Smart Sensor Temperature service for temperature-controlled shipments (RT0005 easy2log Temperature Logger, CAEN RFID).

RFID technology also is the basis for a label that records temperature information. At any point during the distribution process, a wireless reader can collect data from 30 labels located within 60 ft (20 m). Reading distances as great as 300 ft (100 meters) are possible if the line of sight between reader and label is unobstructed. Available in both the United States and Europe, the flat labels are about the size of a credit card (Ultra Wireless Label and Ultra Wireless Reader, PakSense).

Similar capabilities are provided by high-frequency 13.56-MHz RFID tags and readers designed for humid environments (SensTag sensor, Phase VI Engineering, based on the MLX90129 sensor IC, Melexis Microelectronic Integration Systems; 13.56-MHz reader from Proxima RF).

A temperature-control process, designed especially for clinical-trial shipments, consists of an RFID tag for recording temperature, a dedicated compartment for a mobile phone for high-speed data transmission, and a secure web-based portal. Designed to record temperatures between 5 and 35 C at configurable intervals, the device can track more than 8000 data points and operate for nearly 60 days. If the data show that the temperature remained within specifications during shipment, the drug can be released immediately for use (RFID tag, Stora Enso; multimodal communication, MediXine Oy; Clinical Logistics Services, Parexel International).

Standards

Several groups, including the Parenteral Drug Association, the International Safe Transit Association (ISTA), International Air Transport Association, and the US Pharmacopeia are working on tools, guidelines and regulations to support Good Distribution Practices. ISTA recently released its Standard 20: Design and Qualification of Insulated Shipping Containers. It includes multiple appendices and worksheets to support the design, testing, and validation of insulated shipping containers. ISTA's new Standard 7E: Thermal Transport Packaging Used in Parcel Delivery Systems updates Standard 7D.

With the development of Standard 20 and Standard 7E A, ISTA also established new certification categories. A handful of laboratories have completed or are working to be designated as ISTA Certified Thermal Transport Laboratories, and personnel have begun the process to earn Level I or Level II status as ISTA Certified Thermal Professionals. Laboratory certification must be renewed every two years.

Thermal packaging, developed and tested according to the ISTA standards, is designed to simplify the sourcing process and provide confidence in its performance. "Drugmakers will be able to buy ISTA-certified thermal packaging off the shelf with all the necessary documentation and validation information," predicts Ed Church, president of ISTA.

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684,
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